Bladder Cancer, Cancer of Head and Neck, Lung Cancer, Nicotine Dependence, Other Tobacco Product
Conditions
Brief summary
This study will test feasibility, in smokers with lung, head & neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.
Detailed description
The aim of the study is to determine the appeal of e-cigarettes compared to combustible cigarettes as measured by the degree to which patients succeed in reducing their cigarette consumption over the 9 weeks they are supplied with product, along with their consumption of e-cigarettes. We will measure past use of e-cigarettes and cigarettes at baseline, 3, 6, 9, and 12 weeks. We will also assess the effect of e-cigarette substitution on toxicity by measuring expired carbon monoxide and urine NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) , a carcinogenic metabolite of cigarette smoke.
Interventions
DEVICEHALO
HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological or cytological diagnosis of lung, head & neck, or bladder cancer within the past 5 years. 2. AJCC (American Joint Committee on Cancer) stages I-IV 3. Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm 4. Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program) 5. May be receiving anti-cancer agents 6. Age 18 or older 7. Fluent in English; 8. Patient must be capable and willing to provide informed written consent for study participation; 9. Able to participate in study visits
Exclusion criteria
1. Cancer surgery planned in the next 9 weeks; 2. Treatment with radiation planned for the next 9 weeks, 3. Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.) 4. Any use of e-cigarettes in the past 30 days, 5. Pregnant or trying to get pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day | 12 Weeks | Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model. |
| Average Number of E-cigarettes Used Per Day | 12 Weeks | Average number of e-cigarettes used per day over the 12 week period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ecigarette Use Enrolled participants using the e-cigarette. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Ecigarette Use |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 1 / 19 |
Outcome results
Primary
Average Number of E-cigarettes Used Per Day
Average number of e-cigarettes used per day over the 12 week period
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecigarette Use | Average Number of E-cigarettes Used Per Day | 5.04 ecig sessions per day |
Primary
Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day
Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecigarette Use | Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day | 4.37 number of Daily Cigarettes |